Orally consumable films have become important consumer products for the dispensing of such substances as breath fresheners, anti-bacterial compounds, and various confections; and are frequently compounded with sweeteners, preservatives, and other additives. They are commonly made of water-soluble polymers, such as pullulan, as seen in U.S. Pat. Nos. 5,518,902; 5,411,945; and 4,851,394.
Presently, orally consumable films are generally distributed in reclosable packages containing ten or more doses. One dispenser adaptable for flat sheet orally consumable films is taught in U.S. Pat. Appl. Pub. No. 2003/0121932A1. This device uses a roller that can frictionally engage a flat article, such as an orally consumable strip, and dispense it through a slot in an otherwise closed container. An alternative packaging and dispensing system is seen in U.S. Pat. Appl. Pub. No. 2003/0183643A1. In that device, the orally consumable films are contained in a blister pack having an openable back portion that opens and closes the blister pack by means of a resealable pressure sensitive adhesive area. Often such packages are very small and require the user to grip and remove the solid dosage product with a single finger. To ease removal of such small, thin, lightweight products users often lick their finger to increase adhesion of the product to the finger. Obviously, such a procedure has a high probability of contaminating the other products in the packaging and has the potential of totally ruining the products from carryover saliva. Such a contact intensive removal and administration process is entirely unacceptable for medicinal products. Further, both the roller and resealable back blister pack have two serious drawbacks, namely, they are not particularly designed to prevent the dispensing of multiple film dosage forms, nor do they have any child-resistant attributes.
These drawbacks may not be of much consequence in some of the frequent uses of orally consumable films, that is, for candy, breath aids, and the like. In this setting, dosage control and safety from accidental ingestion by children is not particularly important. Representative of these packages are those taught in U.S. Pat. No. 5,354,551. However, these films have been taught as methods of dosing drugs, as for example in U.S. Pat. No. 5,411,945. In such applications, dosage control and child resistance become essential qualities of any practical packaging.
Packaging of individually contained single dosage forms, including but not limited to orally consumable films, has become increasing popular. This is true with both pharmaceutical products as well as consumer products. One obvious advantage of this in the pharmaceutical market is that it substantially reduces the risk of accidental overdose. Additionally, having the product individually wrapped, or housed, eliminates the risk of contaminating other doses of the product. Further, consumers appreciate the feeling obtained when opening an individually wrapped product because they know that they are the only one that has handled the actual product since it was packaged. Further, in this embodiment the chances of the other dosage forms becoming contaminated or losing efficacy from exposure to moisture, light or air is eliminated.
Some drawbacks come along with the benefits of individually packaged products. Perhaps the largest drawback and risk of individually packaged products is the risk posed to children. Individually wrapped products, especially small products such as medications, often resemble candy to a small child. Further, written warnings as to the contents are ineffective for children who cannot read. Most importantly, the vast majority of single dose packaging has not been child-resistant. As such, a demand for child-resistant single dose packaging has surfaced.
Present packaging technologies for individually wrapped candies and non-prescription products such as aspirin are particularly ineffective for the myriad of products that require some degree of child-resistant packaging because such candies and non-prescription product packaging has been designed solely for ease of opening. Additionally, an entirely new class of packaging is required for fast dispersing solid dosage products that are designed to dissolve when exposed to liquid. Most commonly, such fast dispersing solid dosage products are formed as a thin sheet, often less than a tenth of an inch in thickness, that is placed in the mouth to dissolve upon contact with saliva. This method of administration has become increasingly popular with prescription medications as well as consumer products such as breath fresheners. However, the key attribute that has made them popular, namely their dissolution upon contact with a liquid, has made them particularly susceptible to damage. Therefore, a process for forming individual, and individual child-resistant packaging for thin sheet fast dispersing solid dosage products is particularly needed, as well as the need for the packaging itself.
To date, great attention has been focused on designing child-resistant blister packaging for tablet and capsule products. These packages have typically been formed of a rigid transparent top layer which is sealed or otherwise bonded to a backing layer in a manner that provides a cavity, pouch, or “blister” in which the medicament is disposed. Advances in such blister packaging have included the incorporation of features requiring peeling, folding, stripping, and/or rupturing of various portions of the packaging. Unfortunately the advances made in child-resistance for such packaging has little to no relevance to applications for thin sheet type products, particularly when such products are not rigid.
What has been needed, and heretofore unavailable, is a disposable, unit dose pouch for containing thin sheet or film type products that is child-resistant, yet senior-friendly, and allows for easy opening. Such a pouch must be inexpensive and easy to manufacture, maintain the integrity of the unit dose, and must be resistant to opening by children. At the same time, the package must easily be opened by an adult user that may have limited strength, coordination, or sight.